Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05394454
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2022-05-24
Brief Title:
The Effect of Non-invasive Bladder Stimulation Technique on Collecting Urine Specimen in Infants Under One Year Old
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Effect of Non-invasive Bladder Stimulation Technique on Collecting Urine Specimen in Infants Under One Year Old Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary tract infection UTI is common in early childhood The American Academy of Pediatrics accepts suprapubic aspiration and bladder catheterization as the gold standard for the diagnosis of UTI However these techniques are painful and invasive Clean-caught urine provides an acceptable urine specimen for the diagnosis of UTI although this method is possible for toilet-trained children Bladder stimulation maneuvers that allow clean-caught urine specimens have recently been identified in children who are not toilet trained This study was planned to examine the effect of non-invasive bladder stimulation technique used in collecting urine specimen in infants under the age of one on the success of the procedure the duration of the procedure the physiological parameters of the baby and the level of pain
Detailed Description:
Urinary tract infection UTI is a common bacterial infection in early childhood Morello et al 2016 UTI symptoms in infants are nonspecific Therefore it is important to take a good urine specimen for diagnosis In practice different techniques are used to collect urine specimen These techniques are suprapubic aspiration urinary catheterization sterile urine collection bag and cleanly caught urine The American Academy of Pediatrics AAP recommends collecting urine specimen by suprapubic aspiration SPA and urinary catheterization methods for the diagnosis of UTI The sterile urine collection bag is a non-invasive urine collection technique This technique is both time consuming and the urine obtained has high bacterial contamination Kaufman 2020 Clean-caught urine provides an acceptable urine specimen for the diagnosis of UTI However this technique is possible for toilet-trained children Roberts et al 2016
Recently Herreros Fernández et al 2013 described a clean-caught urine collection technique based on bladder stimulation and lumbar paravertebral massage This technique was successful in 86 of newborns with an average duration of 57 seconds
When the literature is reviewed more evidence is needed regarding the bladder stimulation technique in children without toilet training Examining the effects of parasympathetic system stimulating maneuvers on childrens physiological parameters and pain will contribute to more knowledge about the technique
This study will be conducted to investigate the effect of non-invasive bladder stimulation technique on the success of the procedure the duration of the procedure the physiological parameters and the level of pain in collecting urine specimens in infants under the age of one
Study Population and Sampling The study population will consist of infants without toilet training who applied to the Pediatric Emergency Service of a university hospital and whose urine specimen should be collected for diagnostic purposesThe sample of the study will consist of 64 infants Experimental group32 Control group32 under the age of one who applied to the Pediatric Emergency Service of a university hospital met the criteria for inclusion in the study and received written consent from their parents In calculating the sample size Altuntaş et al 2015 benefited from the study Considering the success rates The minimum number of samples to be taken was determined as 64 Experimental group32 Control group32 with 95 confidence 1-α 95 test power 1-β w0453 effect size
Randomization Infants who meet the research sample selection criteria will be assigned to the experimental and control groups using the balanced block randomization method Tran et al 2016 reported increasing age in children as a factor affecting the success of the procedure For this reason the block randomization method will be preferred in order to ensure that the infants are distributed homogeneously according to the age groups In order to assign infants to the experimental and control groups 4 blocks will be created on the computer wwwrandomorg according to age 1-3 months 4-6 months 7-9 months 10-12 months Each block will contain 16 8 experimental 8 control babies
Data Collection Method The data will be collected by the researcher in the unit where the study is planned to be carried out
Data Collection Tools
Data Collection Form Prepared by the researcher The form includes questions about the infants age weight gender whether he is circumcised if male fever heartbeat saturation level FLACC scale score and procedure success and duration of the procedure
The FLACC Pain Scale was developed by Merkel et al in 1997 Five behavioral parameters are evaluated on the FLACC scale Each of the babys facial expression leg movements activity crying and comfortability parameters take the value 0 1 2 The total score is between 0 and 10 Merkel et al 1997 The Turkish validity and reliability of the scale was performed by Şenaylı et al2006
Pulse Oximeter Device to detect the oxygen saturation SPO2 and heart rate HR of infants before during and after the procedure
Intervention
The bladder stimulation technique consists of two consecutive maneuvers In the first maneuver the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute In the second maneuver circular massage is applied to the paravertebral region for 30 seconds The two stimulation maneuvers will be repeated alternately for 3 minutes 180 seconds until micturition begins Maneuvers will be performed by the researcher Infants in both groups will be held under the armpit by a parent male infants will be held in the drooping legs and female infants will be held in the hip flexion position Bladder stimulation technique will be applied to the experimental group but not to the control group
Interventions to be applied to the experimental group
Breastmilkformula milkwater intake appropriate for the infants age and weight will be provided 20-30 minutes before the urine specimen is taken
Before the procedure information about the infant in the data collection form will be recorded
Before the procedure the infant s heart rate saturation level and Flacc scale score will be recorded Scoring of the FLACC pain scale will be done by the researcher and a nurse who is not part of the research team
Genital area will be cleaned before taking urine specimen
İnfant will be held under the armpit by a parent baby boys will be held with their legs hanging down and baby girls will be held in hip flexion position
Infants with spontaneous voiding during the period from the beginning of the research procedure until the infant is positioned will be excluded from the study Instead of the infant excluded the first infant who met the inclusion criteria of the study and presented to the emergency department will be included
The bladder stimulation technique consists of two consecutive maneuvers In the first maneuver the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute In the second maneuver circular massage is applied to the paravertebral region for 30 seconds The two stimulation maneuvers will be repeated alternately for 3 minutes 180 seconds until micturition begins
After the maneuvers are started the infant will be evaluated with the FLACC pain scale at the 1st and 3rd minutes by the researcher and a nurse who is not part of the research team
Heart rate and saturation will be recorded at the 1st and 3rd minutes after the maneuvers are started
The success of the procedure and the duration of the procedure will be recorded
Interventions to be applied to the control group
Breastmilkformula milkwater intake appropriate for the infant s age and weight will be provided 20-30 minutes before the urine specimen is taken
Before the procedure information about the infant in the data collection form will be recorded
Before the procedure the infants heart rate saturation level and Flacc scale score will be recorded Scoring of the FLACC pain scale will be done by the researcher and a nurse who is not part of the research team
Genital area will be cleaned before taking urine specimen
Infant will be held under the armpit by a parent baby boys will be held with their legs hanging down and baby girls will be held in hip flexion position
Infant with spontaneous voiding during the period from the beginning of the research procedure until the baby is positioned will be excluded from the study Instead of excluded infants the first infant who met the inclusion criteria of the study and presented to the emergency department will be included
Bladder stimulation technique will not be applied
The infant will be evaluated by the observers at the 1st and 3rd minutes with the FLACC pain scale
Heart rate and saturation will be recorded at the 1st and 3rd minutes
The success of the procedure and the duration of the procedure will be recorded
Recently Herreros Fernández et al 2013 described a clean-caught urine collection technique based on bladder stimulation and lumbar paravertebral massage This technique was successful in 86 of newborns with an average duration of 57 seconds
When the literature is reviewed more evidence is needed regarding the bladder stimulation technique in children without toilet training Examining the effects of parasympathetic system stimulating maneuvers on childrens physiological parameters and pain will contribute to more knowledge about the technique
This study will be conducted to investigate the effect of non-invasive bladder stimulation technique on the success of the procedure the duration of the procedure the physiological parameters and the level of pain in collecting urine specimens in infants under the age of one
Study Population and Sampling The study population will consist of infants without toilet training who applied to the Pediatric Emergency Service of a university hospital and whose urine specimen should be collected for diagnostic purposesThe sample of the study will consist of 64 infants Experimental group32 Control group32 under the age of one who applied to the Pediatric Emergency Service of a university hospital met the criteria for inclusion in the study and received written consent from their parents In calculating the sample size Altuntaş et al 2015 benefited from the study Considering the success rates The minimum number of samples to be taken was determined as 64 Experimental group32 Control group32 with 95 confidence 1-α 95 test power 1-β w0453 effect size
Randomization Infants who meet the research sample selection criteria will be assigned to the experimental and control groups using the balanced block randomization method Tran et al 2016 reported increasing age in children as a factor affecting the success of the procedure For this reason the block randomization method will be preferred in order to ensure that the infants are distributed homogeneously according to the age groups In order to assign infants to the experimental and control groups 4 blocks will be created on the computer wwwrandomorg according to age 1-3 months 4-6 months 7-9 months 10-12 months Each block will contain 16 8 experimental 8 control babies
Data Collection Method The data will be collected by the researcher in the unit where the study is planned to be carried out
Data Collection Tools
Data Collection Form Prepared by the researcher The form includes questions about the infants age weight gender whether he is circumcised if male fever heartbeat saturation level FLACC scale score and procedure success and duration of the procedure
The FLACC Pain Scale was developed by Merkel et al in 1997 Five behavioral parameters are evaluated on the FLACC scale Each of the babys facial expression leg movements activity crying and comfortability parameters take the value 0 1 2 The total score is between 0 and 10 Merkel et al 1997 The Turkish validity and reliability of the scale was performed by Şenaylı et al2006
Pulse Oximeter Device to detect the oxygen saturation SPO2 and heart rate HR of infants before during and after the procedure
Intervention
The bladder stimulation technique consists of two consecutive maneuvers In the first maneuver the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute In the second maneuver circular massage is applied to the paravertebral region for 30 seconds The two stimulation maneuvers will be repeated alternately for 3 minutes 180 seconds until micturition begins Maneuvers will be performed by the researcher Infants in both groups will be held under the armpit by a parent male infants will be held in the drooping legs and female infants will be held in the hip flexion position Bladder stimulation technique will be applied to the experimental group but not to the control group
Interventions to be applied to the experimental group
Breastmilkformula milkwater intake appropriate for the infants age and weight will be provided 20-30 minutes before the urine specimen is taken
Before the procedure information about the infant in the data collection form will be recorded
Before the procedure the infant s heart rate saturation level and Flacc scale score will be recorded Scoring of the FLACC pain scale will be done by the researcher and a nurse who is not part of the research team
Genital area will be cleaned before taking urine specimen
İnfant will be held under the armpit by a parent baby boys will be held with their legs hanging down and baby girls will be held in hip flexion position
Infants with spontaneous voiding during the period from the beginning of the research procedure until the infant is positioned will be excluded from the study Instead of the infant excluded the first infant who met the inclusion criteria of the study and presented to the emergency department will be included
The bladder stimulation technique consists of two consecutive maneuvers In the first maneuver the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute In the second maneuver circular massage is applied to the paravertebral region for 30 seconds The two stimulation maneuvers will be repeated alternately for 3 minutes 180 seconds until micturition begins
After the maneuvers are started the infant will be evaluated with the FLACC pain scale at the 1st and 3rd minutes by the researcher and a nurse who is not part of the research team
Heart rate and saturation will be recorded at the 1st and 3rd minutes after the maneuvers are started
The success of the procedure and the duration of the procedure will be recorded
Interventions to be applied to the control group
Breastmilkformula milkwater intake appropriate for the infant s age and weight will be provided 20-30 minutes before the urine specimen is taken
Before the procedure information about the infant in the data collection form will be recorded
Before the procedure the infants heart rate saturation level and Flacc scale score will be recorded Scoring of the FLACC pain scale will be done by the researcher and a nurse who is not part of the research team
Genital area will be cleaned before taking urine specimen
Infant will be held under the armpit by a parent baby boys will be held with their legs hanging down and baby girls will be held in hip flexion position
Infant with spontaneous voiding during the period from the beginning of the research procedure until the baby is positioned will be excluded from the study Instead of excluded infants the first infant who met the inclusion criteria of the study and presented to the emergency department will be included
Bladder stimulation technique will not be applied
The infant will be evaluated by the observers at the 1st and 3rd minutes with the FLACC pain scale
Heart rate and saturation will be recorded at the 1st and 3rd minutes
The success of the procedure and the duration of the procedure will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None